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Dimension Vista System - Enzyme Calibrator (2014-01-20)

Starting date:
January 20, 2014
Posting date:
February 11, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-37925

Recalled products

  1. Dimension Vista System - Enzyme Calibrator 

Reason

There have been reports of quality control (QC) shifts with pseudocholinesterase (PCHE) and imprecision during PCHE calibration with Dimension Vista enzyme 1 calibrator (ENZ 1 cal) lots 3FD034 and 3HD012. Investigation by Siemens confirms a loss of PCHE activity in the affected lots of enzyme 1 calibrator, causing an elevation of qc by as much as 80% and in some instances, imprecision of replicates during calibration.

Affected products

A. Dimension Vista System - Enzyme Calibrator 

Lot or serial number
  • 3FD034
  • 3HD012
Model or catalog number
  • KC310
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES